Project Relay Model for Recruiting Alcohol Dependent Patients in General Hospitals (Relay)
Primary Purpose
Alcohol Use Disorder, Alcohol Dependency
Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Relay Model
Sponsored by
About this trial
This is an interventional health services research trial for Alcohol Use Disorder focused on measuring Alcohol use disorder, Motivational Intervention, Health expenditures, efficacy study
Eligibility Criteria
Inclusion Criteria:
- Hospitalized for a minimum of 24 hours
- Resident within the uptake area of the involved alcohol treatment centres
- Willing to participate in the study
- Cognitive and physical capable
Exclusion Criteria:
- In any alcohol-specific treatment for alcohol dependence
- Psychotic
- Less than 18 years of age
- Hospitalized less than 24 hours
- Resident outside uptake areas
- Not consenting on participation in the study
- Cognitive and physical incapable
Sites / Locations
- RESCueH alcohol Studies, Unit of Clinical Alcohol Research, Psyciatric Research Unit, Clinical Institute, University of Southern Denmark
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
No Intervention
Arm Label
Relay Model
Usual Referral Procedure
Arm Description
AUDIT score 8+: Brief Motivational Intervention with alcohol therapist. AUDITscore16+:Brief Motivational Intervention and appointment at Alcohol Treatment Clinic -
Hospital staff refer patient to Alcohol Treatment Clinic according to usual procedure
Outcomes
Primary Outcome Measures
health care expenditures
Primary measure is Health care expenditures 12 months after discharge, according to the International Classification of Health Accounts, extracted from population registers.
Secondary Outcome Measures
report to alcohol clinic
Secondary outcome is the percentage of the target group, who, 30 days after discharge, reports at the alcohol treatment clinics.
Full Information
NCT ID
NCT02188043
First Posted
July 9, 2014
Last Updated
September 28, 2017
Sponsor
University of Southern Denmark
1. Study Identification
Unique Protocol Identification Number
NCT02188043
Brief Title
Project Relay Model for Recruiting Alcohol Dependent Patients in General Hospitals
Acronym
Relay
Official Title
Relay Model for Recruiting Alcohol Dependent Patients in General Hospitals - A Single-blind Pragmatic Randomised Trial
Study Type
Interventional
2. Study Status
Record Verification Date
September 2017
Overall Recruitment Status
Completed
Study Start Date
November 2013 (undefined)
Primary Completion Date
June 2017 (Actual)
Study Completion Date
June 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Southern Denmark
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to evaluate the Relay Model helping alcohol dependent patients at a general hospital to start specialized alcohol treatment in order to assess i) efficacy, ii) cost-effectiveness and iii) overall societal cost impacts.
The effect of the Relay Model will be investigated in a single-blind pragmatic randomised controlled trial in which the control group consists of patients referred to treatment by usual procedures.
Detailed Description
An increase in individuals with alcohol dependence receiving specialized alcohol treatment will be of major importance for society's response to alcohol problems and its consequences. The Danish population has a large intake of alcohol. Approximately 20% of the adult population are heavy drinkers ( >14/21 drinks/ week (women/men)), 14% are harmful users, and 3% are dependent drinkers. Untreated alcohol use disorders lead to frequent contacts to the health care system associated with considerable human and societal costs. A first approach would be to identify and recruit patients from general hospitals, where the proportion of inpatients with alcohol use disorders range between 16 % and 26%. A referral model to ensure treatment for alcohol dependent patients after discharge is needed.
The main objective of the study is to develop strategies which increase the likelihood that patients report for outpatient alcohol treatment after discharge. It is likely that an optimization of the transfer procedure between hospital and outpatient clinic will lead to that more patients will be engage in psychosocial treatment for their alcohol abuse, which will improve the prognosis, reduce re-admissions and the use of hospital beds and, thus have positive economic consequences. We evaluate the Relay Model in order to assess i) efficacy, ii) cost-effectiveness and iii) overall societal cost impacts.
The target group of the present study is patients suffering from alcohol dependence admitted to a general hospital located in an urban area and a general hospital located in a rural area.
A single-blind pragmatic randomised controlled trial including patients admitted to Hospital. The study group(n=500) receive an Intervention and the control group(n=500) are referred to treatment by usual procedures. All patients complete a lifestyle questionnaire with the Danish self-report version of the Alcohol Use Disorders Identification Test (AUDIT) embedded as a case identification strategy. The patients are informed that an alcohol therapist may contact them and give feedback on their responses.
The completed forms are reviewed daily and an AUDIT score of 8+prompts a call to the Alcohol therapist, who attends the departments on different days randomly drawn by a computer. The RELAY MODEL intervention include a Brief Motivational Intervention. Patients who score AUDIT 16+ are also offered an appointment at the alcohol treatment clinic.
Primary measure is health care expenditures 12 months after discharge, according to the International Classification of Health Accounts, extracted from population registers. The analysis will be repeated on a yearly basis during the following 5 years.
Secondary outcome: The percentage of the target group, who, 30 days after discharge, reports at the alcohol treatment clinics.
A multiple regression model will be used. Since non-treated alcohol disorders generate a high number of societal costs annually for health care, social services, traffic accidents, criminal activities and lost productions we believe the Relay Model to be either cost-neutral or cost-effective, i.e. low net costs compared to effectiveness. We expect to establish evidence that the Relay Model is either cost-neutral or cost-effective, compared to referral by usual procedures.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Use Disorder, Alcohol Dependency
Keywords
Alcohol use disorder, Motivational Intervention, Health expenditures, efficacy study
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
1000 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Relay Model
Arm Type
Other
Arm Description
AUDIT score 8+: Brief Motivational Intervention with alcohol therapist. AUDITscore16+:Brief Motivational Intervention and appointment at Alcohol Treatment Clinic
-
Arm Title
Usual Referral Procedure
Arm Type
No Intervention
Arm Description
Hospital staff refer patient to Alcohol Treatment Clinic according to usual procedure
Intervention Type
Behavioral
Intervention Name(s)
Relay Model
Intervention Description
The Clinical staff hand out and collect lifestyle - questionnaires to admitted patients, and screen by 10 alcohol questions (AUDIT) , and report score to outpatient Alcohol Clinic.
Based on the questionnaire that the patient filled out, the Alcohol therapist perform a brief Motivational Intervention on patients with an AUDIT score of 8+, focusing the patients alcohol consumption habits and offer an appointment to patients with an AUDIT score of 16+.
Primary Outcome Measure Information:
Title
health care expenditures
Description
Primary measure is Health care expenditures 12 months after discharge, according to the International Classification of Health Accounts, extracted from population registers.
Time Frame
12 - 60 months
Secondary Outcome Measure Information:
Title
report to alcohol clinic
Description
Secondary outcome is the percentage of the target group, who, 30 days after discharge, reports at the alcohol treatment clinics.
Time Frame
30 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Hospitalized for a minimum of 24 hours
Resident within the uptake area of the involved alcohol treatment centres
Willing to participate in the study
Cognitive and physical capable
Exclusion Criteria:
In any alcohol-specific treatment for alcohol dependence
Psychotic
Less than 18 years of age
Hospitalized less than 24 hours
Resident outside uptake areas
Not consenting on participation in the study
Cognitive and physical incapable
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bent Nielsen, Ph.D
Organizational Affiliation
bent.nielsen@rsyd.dk
Official's Role
Principal Investigator
Facility Information:
Facility Name
RESCueH alcohol Studies, Unit of Clinical Alcohol Research, Psyciatric Research Unit, Clinical Institute, University of Southern Denmark
City
Odense
ZIP/Postal Code
DK - 5000 C
Country
Denmark
12. IPD Sharing Statement
Citations:
PubMed Identifier
27080865
Citation
Schwarz AS, Bilberg R, Bjerregaard L, Nielsen B, Sogaard J, Nielsen AS. Relay model for recruiting alcohol dependent patients in general hospitals--a single-blind pragmatic randomized trial. BMC Health Serv Res. 2016 Apr 14;16:132. doi: 10.1186/s12913-016-1376-8.
Results Reference
derived
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Project Relay Model for Recruiting Alcohol Dependent Patients in General Hospitals
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